Comment from Noetik
AnonymousSupportBusiness
Summary: Noetik, an AI-native oncology company, supports the FDA's pilot program for using AI to optimize early-phase clinical trials. They recommend prioritizing oncology trials, establishing a coordinated regulatory engagement track, and ensuring the pilot includes a significant share of slots for small and mid-size AI-native sponsors.
Noetik appreciates the Agency’s commitment to conduct a pilot program for optimization of early-stage clinical trials using AI-enabled technologies.
Noetik is an AI-native clinical-stage oncology company founded in 2022. Our mission is to leverage advanced machine learning methods to discover and develop cancer therapies.
Our current focus has been on predicting therapeutic response as the most direct application of AI on patient outcomes. In support of this goal, we submit the following comments for consideration by the Agency (attached as pdf).